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IRCT20210204050243N1 IRCT 2021-05-07 Iran University of Medical Sciences Evaluation of the effect of norepinephrine, ephedrine and phenylephrine in treatment of hemodynamic changes in spinal anesthesia in Caesarean section surgeries Evaluation of the effect of norepinephrine, ephedrine and phenylephrine on prophylaxis and treatment of hemodynamic changes of spinal anesthesia in elective Caesarean section surgeries 2021-03-21 anticipated 45 Complete https://irct.ir/trial/54421 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this current study a permuted block randomization technique will be used in which the randomization will be conducted right before the patients admission. Taking in consideration that 45 patients will be participated in this study which will be divided in 15 blocks each with three sections. First of all 15 blocks each with three sections , in each different methods of treatment included, will be conducted. After forming 15 blocks , all of them will be put in a non transparent envelope and then in a specific vase. Then in each stage an envelope will be selected randomly and will be registered in a predetermined table. For instance, the combination of the first block will be N,P,E in which the first patient will receive the treatment in group N and the second will receive the treatment in group P and the third will receive the treatment in group E, and this will continue until all 15 blocks will be selected. All of these steps will be done before sampling . For allocation concealment, the blocks will be put in a non transparent envelope with no names of the drugs that will be used in this study mention on the envelope. The intervention of the first patient will be unknown until the sampling is completed, Blinding description: This is a double blinded study in which both the participants and the investigators will not be informed on grouping the patients and the related outcomes. 2 Hemodynamic changes of spinal anesthesia. Intervention 1: Intervention group 1 : Right after spinal anesthesia is done 5 micrograms of norepinephrine will be administered then the patient’s vital signs will be documented every one minute till birth then every 5 minutes till end of surgery. Intervention 2: Intervention group2: Right after spinal anesthesia is done 40 micrograms of phenylephrine will be administered then the patient’s vital signs will be documented every one minute till birth then every 5 minutes till end of surgery. Intervention 3: Intervention group3: Right after spinal anesthesia is done 5 milligrams of ephedrine will be administered then the patient’s vital signs will be documented every one minute till birth then every 5 minutes till end of surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Rima Alghozat
Rasoul Akram hospital , Maziyar Mansouri St , Sattar Khan
Tehran Iran (Islamic Republic of) 1998733191 +98 21 2214 7094 rimaghozat1989@yahoo.com Iran University of Medical Sciences scientific Rima Alghozat
Rasoul Akram hospital, Maziyar Mansouri St, Sattar Khan
Tehran Iran (Islamic Republic of) 1998733191 +98 21 2214 7094 rimaghozat1989@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Patient consent Gestational age >36 wks Height>150 cm Age 18 -40 years Weight 60 kg - 80 kg 18 years 40 years Female Spinal block failure Preeclampsia History of hypertension Gestational age of < 36 wks Multiple gestation Height < 150 cm Opium addiction Contraindication of spinal anesthesia History of heart disease Patient discontent O74.5 Spinal and epidural anesthesia-induced headache during labor and delivery Prevention Prevention Prevention Intervention group 1 : Right after spinal anesthesia is done 5 micrograms of norepinephrine will be administered then the patient’s vital signs will be documented every one minute till birth then every 5 minutes till end of surgery. Intervention group2: Right after spinal anesthesia is done 40 micrograms of phenylephrine will be administered then the patient’s vital signs will be documented every one minute till birth then every 5 minutes till end of surgery. Intervention group3: Right after spinal anesthesia is done 5 milligrams of ephedrine will be administered then the patient’s vital signs will be documented every one minute till birth then every 5 minutes till end of surgery. The percentage of women with low blood pressure and heart rate. Timepoint: Right after basic monitoring then every one minute right after the spinal anesthesia is done till the birth and then every five minutes till the end of the surgery. Method of measurement: Blood pressure monitor and pulse oximeter. Iran University of Medical Sciences Approved 2020-11-01 Ethics committee of Iran University of Medical Sciences Rasoul Akram hospital, Maziyar Mansouri street , Sattar Khan Tehran Tehran Iran (Islamic Republic of)